Circular stapling systems and instruments

Abstract

Systems, devices and methods are provided for introducing and removing collapsible anvils to and from a target site in a patient, such as a proximal bowel during a colon resection procedure. A delivery instrument for a circular stapler having an anvil comprises an elongate shaft with first and second jaws movable between open and closed positions and a driver extending through the shaft. The driver has an engagement mechanism for engaging the anvil and moving the anvil between a collapsed configuration and an expanded configuration. The instrument allows the surgeon to introduce the anvil in a collapsed state through a percutaneous penetration in the patient, such as a cannula, and then expand the anvil within the target site in the proximal bowel for the stapling operation. In addition, the instrument allows the surgeon to collapse the anvil to facilitate removal of the anvil and reduce stress on the staple line.

Description

CIRCULAR STAPLING SYSTEMS AND INSTRUMENTSCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application Serial Nos. 63 / 621,462 and 63 / 621,490, filed January 16, 2024, the complete disclosures of which are incorporated herein by reference for all purposes.TECHNICAL FIELD

[0002] This description generally relates to endoscopic surgical instruments for dissecting, occluding and / or sealing tissue, and more particularly to endoscopic circular stapler devices that are particularly useful for joining tubular tissue structures together and instruments and systems for deploying such circular stapler devices.BACKGROUND

[0003] In certain types of surgical procedures, the use of surgical staples has become the preferred method of joining tissues and, therefore, specially configured surgical staplers have been developed for different applications. For example, intraluminal or circular staplers have been developed for use in joining two tubular structures together, such as surgical procedures involving the lower colon wherein two separated regions of the lower colon are joined together in an anastomosis after a target area has been resected.

[0004] Circular staplers typically comprise an elongate shaft, which has a proximal actuation mechanism and a distal stapling mechanism mounted on the shaft. The distal stapling mechanism typically includes a stapling cartridge that houses a plurality of staples arranged in a concentric circular array. An annular cutting knife is mounted concentrically with the staples within the cartridge or the end effector of the instrument so that it can move axially relative to the cartridge. A movable trocar shaft or capturing spike extends axially from the center of the instrument to detachably couple the anvil to the stapling mechanism. The anvil is configured to shape the end of the staple as the staple is driven into the anvil. The distance between the distal surface of the staple cartridge and the staple anvil is typically controlled by an adjustment mechanism mounted at the proximal end of the stapler shaft to control the axial movement of the capturing spike.

[0005] When performing a lower colon procedure using a circular stapler, the surgeon typically uses a conventional linear stapler with two rows of staples placed on either side of the affected intestinal lesion to be removed and stapled. The target area is cut at the same time as the adjacent ends are stapled. After removing the affected area, the surgeon typically inserts the anvil of the circular stapler into the proximal end of the lumen, proximal of the staple line. This is done by inserting the anvil head into an entrance that has been cut into the proximal lumen by the surgeon. Sometimes an anvil can be placed transanally by placing the anvil head at the distal end of the stapler and inserting the instrument through the rectum. The proximal end of the intestine is then tied to the anvil shaft using a purse string suture or other conventional tying device and the proximal and distal ends of the intestine are tightened within the gap by closing the gap between the anvil and the cartridge. The circular stapler is then actuated to join the ends and form a tubular passage by driving and forming multiple annular rows of staples through both ends of the intestine. At the same time as the staples are driven and formed, a concentric circular knife blade is driven through the end of the intestinal tissue to cut the end adjacent to the inner row of staples.

[0006] After the proximal and distal ends of the intestines have been joined together, the anvil must be removed from the proximal bowel. The anvil, however, typically has a diameter larger than the diameter of the staple line. Thus, withdrawing the anvil through the staple line to remove it from the patient may induce stress on the staple line, which creates the risk of tearing the stapled array and therefore causing an anastomotic leakage.

[0007] To overcome these drawbacks, collapsible anvils have been developed that are configured to fold or collapse into a configuration with a smaller diameter to facilitate their removal through the staple line. These collapsible anvils must be introduced into the patient in a collapsed state and then expanded and manipulated to the target site within the proximal bowel end. In addition, these anvils should be maintained in their expanded shape during the stapling operation and then collapsed again when it is time to remove them.

[0008] Accordingly, it would be desirable to provide delivery instruments and systems for introducing and removing collapsible anvils to and from a target site in a patient, such as the proximal bowel.SUMMARY

[0009] The following presents a simplified summary of the claimed subject matter in order to provide a basic understanding of some aspects of the claimed subject matter. This summary is not an extensive overview of the claimed subject matter. It is intended to neither identify key or critical elements of the claimed subject matter nor delineate the scope of the claimed subject matter. Its sole purpose is to present some concepts of the claimed subject matter in a simplified form as a prelude to the more detailed description that is presented later.

[0010] In one aspect, a delivery instrument for a circular stapler having an anvil is provided. The instrument comprises an elongate shaft with first and second jaws movable between open and closed positions and a driver extending through the shaft. The driver has an engagement mechanism for engaging the anvil and moving the anvil between a collapsed configuration and an expanded configuration. The instrument allows the surgeon to introduce the anvil in a collapsed state through a percutaneous penetration in the patient, such as a cannula, and then expand the anvil within the target site, such as the proximal bowel, for the stapling operation. In addition, the instrument allows the surgeon to collapse the anvil to facilitate removal of the anvil and reduction of stress on the staple line.

[0011] In various embodiments, the driver comprises a rod extending at least partially through the first and second jaws. The engagement element may comprise a rotatable element on a distal end of the rod, or the engagement element may comprise a distal portion of the rod. The rod is configured to cooperate with an interface on the anvil such that rotation of the rod relative to the instrument shaft (or rotation of the rotatable element relative to the rod) causes the anvil to move between the collapsed and expanded configurations.

[0012] In another embodiment, the driver comprises a rod extending at least partially through the first and second jaws. The rod is movable in a longitudinal direction relative to the elongate shaft of the instrument to move the anvil between the collapsed and expanded configurations.

[0013] In various embodiments, the anvil comprises a head and a proximal shaft. The anvil head comprises a tissue contacting surface defining staple forming pockets for receiving staples. The head is configured to pivot relative to the shaft between a collapsed configuration, wherein the head is oriented substantially parallel to the shaft, and an expanded configuration, wherein the head is oriented substantially perpendicular to the shaft. The head has a smaller cross-sectional area or lateral dimension (relative to the longitudinal axis of the shaft) in the collapsed configuration than in the expanded configuration. In an exemplary embodiment, the anvil has an outer dimension or diameter of less than about 14 mm in the collapsed configuration such that the anvil may be advanced through a cannula or other percutaneous entry point in the patient. The anvil may have an outer dimension or diameter in the expanded configuration of at least about 20 mm, or at least about 25 mm.

[0014] In various embodiments, the first and second jaws of the instrument are sized to contact and engage an outer surface of the proximal shaft of the anvil in the closed position. The jaws are substantially parallel to each other and in contact with the outer surface of the anvil shaft in the closed position. This configuration provides a stronger grip on the anvil shaft and inhibits the shaft from slipping out or watermelon seeding from the jaws.

[0015] In various embodiments, the instrument jaws and / or the driver are configured for coupling to a teleoperated or robotic control system that is controlled remotely by a user. In one such embodiment, the driver comprises a proximal end portion configured for coupling to an actuator that controls the driver. The actuator may be located in a proximal handle of the instrument, or remotely in a housing within the operating room. The control system comprises an input device coupled to a controller that allows the user to control the actuator from a remote location.

[0016] In another aspect, a circular stapler system comprises a staple assembly comprising a plurality of staples and a cutting element and an anvil movably coupled to the stapling assembly. The anvil is configured for deploying between a collapsed configuration and an expanded configuration. The system further includes a delivery instrument comprising an engagement mechanism for engaging the anvil and moving the anvil between the collapsed and expanded configurations.

[0017] In various embodiments, the anvil is pivotable between the collapsed and expanded configurations. In one such embodiment, the anvil comprises a head and a shaft. The head is pivotable relative to the shaft from the collapsed configuration, wherein the head is oriented substantially parallel with the shaft, to the expanded configuration, wherein the head is oriented substantially perpendicular to the shaft.

[0018] In one such embodiment, the anvil head comprises a central component and first and second lateral components. The central component is pivotally coupled to the shaft such that it is movable between the collapsed and expanded configurations. In addition, the first and second lateral components are pivotally coupled to central component and configured to fold inwards towards the central component to further reduce the overall cross-sectional area or lateral dimension of the anvil.

[0019] In various embodiments, the engagement mechanism comprises a rod extending at least partially between the first and second jaws. The rod includes a distal end portion configured to pivot the central component of the anvil between the collapsed and expanded configurations. The rod may also be configured to fold the lateral components inwards towards the central component. Alternatively, the instrument may include a second driver for engaging and deploying the lateral components.

[0020] In another aspect, a robotic control system comprises a circular stapler comprising a staple assembly, an anvil movably coupled to the staple assembly and an instrument configured for moving the anvil from a collapsed configuration to an expanded configuration. The system further includes a robotic controller configured to control the instrument.

[0021] In various embodiments, the system further comprises an input device coupled to the controller and movable by the user such that movement of the input device generates an input signal. The controller is coupled to an actuator configured to control a driver on the instrument to move the anvil between the collapsed and expanded configurations based on the input signal.

[0022] In various embodiments, the system further comprises one or more sensor(s) coupled to the controller for detecting a force or torque applied by the robotic controller to the instrument. In other embodiments, the system comprises one or more sensor(s) coupled to the controller for detecting a force or torque applied by the instrument to the anvil. The controller is configured to receive this force / torque information from the sensors and to provide user input on the amount of force applied to tissue during the expansion or manipulation of anvil within the patient. This torque / force feedback may be used as deployment diagnostic to optimize placement of the anvil at the target location and / or to provide additional safety measures for the patient. For example, the system may comprise a processor that is configured to alert the user and / or automatically override the driver within the instrument to stop the expansion of anvil if, for example, the force exerted thereon exceeds a threshold amount.

[0023] In another aspect, a method of joining two tissue structures comprises introducing an anvil in a collapsed configuration through a cannula adjacent to a first tissue structure within a patient and moving the anvil from the collapsed configuration into an expanded configuration. The method further comprises positioning a staple assembly adjacent to a second tissue structure within the patient and advancing a plurality of staples into the first and second tissue structures to attach the first tissue structure to the second tissue structure.

[0024] In various embodiments, the method further includes grasping a shaft of the anvil to move the anvil to the first tissue structure. The shaft may be grasped by a pair of jaws on the instrument. The jaws are movable into a closed position, wherein the jaws are sized to contact and engage an outer surface of the proximal shaft of the anvil in the closed position. The jaws are substantially parallel to each other and in contact with the outer surface of the anvil shaft in the closed position.

[0025] In various embodiments, the method comprises rotating an actuator within a delivery instrument to move the anvil into the expanded configuration. In other embodiments, the actuator is advanced or withdrawn in a longitudinal direction to move the anvil into the expanded configuration.

[0026] The two tissue structures may comprise tubular structures, such as two separate sections of an intestine. The method further comprises advancing a staple pusher to drive staples through the two tissue structures against the anvil to join the first tissue structure to the second tissue structure. The method may further comprise advancing a knife to sever the tissue structures adjacent a row of staples.

[0027] In various embodiments, the method further comprises collapsing the anvil with the instrument actuator and withdrawing the anvil form the first tissue structure to complete the anastomosis.

[0028] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the description. Additional features will be set forth in part in the description which follows or may be learned by practice of the description.BRIEF DESCRIPTION OF THE DRAWINGS

[0029] The above and other aspects, features, and advantages of the present surgical instruments will become more apparent in light of the following detailed description when taken in conjunction with the accompanying drawings in which:

[0030] FIG. 1 is a perspective view of a distal end of a circular stapler;

[0031] FIGS. 2A-2C illustrate one embodiment of an anvil of the circular stapler;

[0032] FIG. 3 is a perspective view of the distal end portion of a delivery instrument for the anvil;

[0033] FIG. 4 illustrates the delivery instrument with closed jaws for advancing the anvil to a target region within a patient;

[0034] FIG. 5 illustrates the delivery instrument after expanding the anvil at the target region;

[0035] FIG. 6 illustrates the delivery instrument manipulating a shaft of an anvil of a circular stapler;

[0036] FIG. 7 illustrates the jaws of the delivery instrument grasping the anvil shaft;

[0037] FIG. 8 schematically illustrates operation of the circular stapler for sealing and cutting tissue;

[0038] FIG. 9 illustrates another embodiment of a collapsible anvil for a circular stapler;

[0039] FIGS. 10A-10C illustrate the deployment of an anvil head of the anvil of FIG. 9;

[0040] FIGS. 11A and 11B illustrates another embodiment of an anvil for a circular stapler;

[0041] FIG. 12A illustrates another embodiment of an anvil for a circular stapler in an expanded configuration;

[0042] FIG. 12B illustrates the anvil of FIG. 12A in an expanded configuration;

[0043] FIGS. 13A and 13B illustrate another embodiment of a collapsible anvil for a circular stapler;

[0044] FIGS. 14A-14C illustrate deployment of the anvil of FIGS. 13A and 13B;

[0045] FIGS. 15A and 15B illustrate another embodiment of a collapsible anvil for a circular stapler;

[0046] FIGS. 16A-16C illustrate another embodiment of a collapsible anvil for a circular stapler;

[0047] FIGS. 17A and 17B illustrate another embodiment of a collapsible anvil for a circular stapler;

[0048] FIGS. 18A-18C illustrates deployment of the anvil of FIGS. 17A and 17B;

[0049] FIGS. 19A and 19B are perspective view of representative teleoperated surgical instruments;

[0050] FIG. 20 illustrates a top view of an operating room employing a robotic surgical system; and

[0051] FIG. 21 illustrates a simplified side view of a robotic arm assembly.DETAILED DESCRIPTION

[0053] Particular embodiments of the present surgical instruments are described hereinbelow with reference to the accompanying drawings; however, it is to be understood that the disclosed embodiments are merely exemplary and may be embodied in various forms. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the devices herein in virtually any appropriately detailed structure. Well-known functions or constructions are not described in detail to avoid obscuring the present description in any unnecessary detail. Like numbers in two or more figures represent the same or similar elements. Furthermore, elements and their associated aspects that are described in detail with reference to one embodiment may, whenever practical, be included in other embodiments in which they are not specifically shown or described. For example, if an element is described in detail with reference to one embodiment and is not described with reference to a second embodiment, the element may nevertheless be claimed as included in the second embodiment. Moreover, the depictions herein are for illustrative purposes only and do not necessarily reflect the actual shape, size, or dimensions of the system or illustrated components.

[0054] While the following is presented with respect to systems and devices for delivering and manipulating circular stapling instruments, it should be understood that certain features of the presently described surgical instruments may be readily adapted for use in delivery instruments for any type of surgical clamping, cutting, ligating, dissecting, clipping, cauterizing, suturing and / or sealing instrument, whether or not the surgical instrument applies a staple or other type of fastener. Additionally, the features of the presently described circular stapling instruments may be readily adapted for use in surgical instruments that are actuated using any technique within the purview of those skilled in the art, such as, for example, manually activated surgical instruments, powered surgical instruments (e.g., electro-mechanically powered instruments), robotic surgical instruments, and the like.

[0055] The devices described herein, or certain components of the devices, may also be incorporated into a variety of different surgical instruments, such as those described in commonly assigned, co-pending U.S. Patent Application Nos. 12 / 945,541, 16 / 205,128, 16 / 427,427, 16 / 678,405, 16 / 904,482, 17 / 081,088 and 17 / 084,981 and International Patent Nos. PCT / US2017 / 056075, PCT / US2017 / 050760, PCT / US2019 / 107646, PCT / US2019 / 019501, PCT / US2019 / 062344, PCT / US2020 / 54568, PCT / US2019 / 064861, PCT / US2019 / 062768, PCT / US2020 / 025655, PCT / US2020 / 056979, PCT / US2019 / 066513, PCT / US2020 / 020672, PCT / US2019 / 066530 and PCT / US2020 / 033481, the complete disclosures of which are incorporated by reference herein in their entirety for all purposes as if copied and pasted herein.

[0056] Fig. 1 illustrates a distal portion of a surgical circular stapling instrument 100 in accordance with an illustrative embodiment. Surgical instrument 100 includes an end effector 110, an elongated shaft 105 and, in some embodiments, a wrist assembly (not shown) coupling end effector 110 to shaft 105. End effector 110 generally comprises a circular stapling assembly 120, an anvil 130 and a capturing device (not shown) for advancing and retracting anvil 130 relative to stapling assembly 120, as discussed in more detail below. Staple assembly 120 comprises a housing having a substantially cylindrical main body with an internal channel for receiving a cutting element assembly, a staple pusher and a staple cartridge (not shown). Stapling assembly 120 may be removably coupled to shaft 105, or permanently affixed thereto. In certain embodiments, stapling assembly 120 is a disposable component of instrument 120 and may be removably attached to shaft 105. In other embodiments, staple cartridge is a disposable component of instrument and may be removably coupled to staple assembly 120. In other embodiments, the entire instrument 120 is manufactured together and may be either a disposable or reusable instrument.

[0057] The proximal end portion of elongate shaft 105 is operatively connected to an actuation mechanism (not shown), although as those skilled in the art reading this description will appreciate, components of the actuation mechanism may extend into, and / or pass through elongated shaft 105 and / or the wrist assembly. In various embodiments, instrument 100 will include a proximal handle (not shown) for actuating the end effector 110 and, in some embodiments, for controlling the orientation and movement of end effector 110. In other embodiments, instrument 100 is adapted to be used with a robotic system. In these embodiments, instrument 100 will generally include an actuation mechanism that controls the orientation and movement of the end effector. The actuation mechanism will typically be controlled by a robotic manipulator assembly that is controlled remotely by a user. For example, in one configuration, the actuation mechanism will be manipulated by the robotic manipulator assembly to move capturing device 140 towards and away from stapling assembly 120 and / or to deploy staples and a cutting element, such as a knife (discussed in more detail below).

[0058] The actuation mechanism may include input couplers (not shown) instead of, or in addition to, the stationary and movable handles. In certain embodiments, surgical instrument 100 will further include a backend mechanism 510 (see FIG. 10A) coupled to the proximal end portion of elongate shaft 105. The backend mechanism typically provides a mechanical coupling between the drive tendons, rods or cables of the instrument and motorized axes of the mechanical interface of a drive system. Further details of known backend mechanisms and surgical systems are described, for example, in U.S. Pat. No. 8,597,280, U.S. Pat. No. 7,048,745, and U.S. Pat. No. 10,016,244. Each of these patents is hereby incorporated by reference in its entirety.

[0059] The input couplers may interface with, and be driven by, corresponding output couplers (not shown) of a telesurgical surgery system, such as the system disclosed in U.S. Pub. No. 2014 / 0183244A1, the entire disclosure of which is incorporated by reference herein. The input couplers are drivingly coupled with one or more input members (not shown) that are disposed within the instrument shaft 105. The input members are drivingly coupled with the end effector 110. Suitable input couplers can be adapted to mate with various types of motor packs (not shown), such as the stapler-specific motor packs disclosed in U.S. Pat. No. 8,912,746, or the universal motor packs disclosed in U.S. Pat. No. 8,529,582, the disclosures of both of which are incorporated by reference herein in their entirety. Further details of known input couplers and surgical systems are described, for example, in U.S. Pat. No. 8,597,280, U.S. Pat. No. 7,048,745, and U.S. Pat. No. 10,016,244. Each of these patents is hereby incorporated by reference in its entirety for all purposes.

[0060] While described herein with respect to an instrument configured for use with a robotic surgical system, it should be understood that the actuation and drive assemblies described herein may be incorporated into manually actuated instruments, electro-mechanical powered instruments, or instruments actuated in any other way. For example, the actuation mechanism may comprise a handle assembly for gripping by the user that includes a stationary handle and a moveable handle, which serves as an actuator for surgical instrument 100.

[0061] Referring now to FIGS. 2A-2C, a representative anvil 130 includes an anvil head 132 and an anvil shaft 134. Anvil shaft 134 is insertable into an internal channel of staple assembly 120 and is removably and slidably securable therein. The capturing device (not shown) is configured to advance and withdraw through this internal channel to translate anvil 130 along a longitudinal axis relative to staple assembly 120 to approximate or un-approximate anvil 130 relative to staple assembly 120. As shown in FIG. 1, anvil head 132 includes a tissue contacting surface 136 defining staple forming pockets (not shown) for receiving staples 200 (see FIG. 9 discussed below).

[0062] Anvil head 132 comprises a central component 140 and first and second lateral components 142, 144. In one embodiment, central component 140 forms the central portion of a generally circular head 132 and lateral components 142, 144 each comprise a semi-circular outer portion of the circular head 132. In an exemplary embodiment, lateral components 142, 144 generally have the same size and shape, although it will be understood that one of the lateral components may be larger than the other.

[0063] As shown in FIG. 2B, central component 140 is pivotally coupled to shaft 134 such that it is movable from a collapsed configuration, wherein central component 140 extends in a direction transverse, or substantially parallel to, shaft 134 (FIG. 2B), to an expanded configuration, wherein central component 140 extends in a direction traverse to, or substantially perpendicular to, shaft 134 (FIG. 2C). In addition, first and second lateral components 142, 144 are pivotally coupled to central component 140 such that they are movable between a collapsed configuration (FIG. 2B), wherein they are folded together towards central component 140 and extend substantially perpendicular to central component 140, to an expanded configuration, wherein lateral components 142, 144 extends substantially parallel to central component 140 to form an anvil suitable for cooperation with staple assembly 120 (FIG. 2C).

[0064] Anvil 130 is configured such that it has a smaller cross-sectional area or lateral dimension (relative to the longitudinal axis of shaft 134) in the collapsed configuration than in the expanded configuration. Lateral dimension is herein defined as the radial distance from the longitudinal axis of shaft to the furthest radial surface or point of the anvil 130 from the longitudinal axis. In certain embodiments, anvil 130 has a lateral dimension (or diameter in certain embodiments) of less than about 14 mm in the collapsed configuration such that anvil 130 may be advanced through a cannula or other percutaneous entry point in the patient. Anvil 130 may have a lateral dimension (or diameter) of at least about 20 mm or at least about 25 mm, or about 21 to about 33 mm in the expanded configuration, although it will be recognized that the dimensions of anvil 130 may vary depending on the surgical procedure and the size of the percutaneous entry point into the patient.

[0065] Anvil head 132 is configured such that when central portion 140 and lateral portions 142, 144 are in the expanded configuration, they form a substantially circular disc. The disc has sufficient rigidity to withstand the forces of clamping and / or driving staples through the tissue against the staple pockets on the proximal surface of head 132. In addition, the staples pockets are aligned with the circumferential staples that are driven against these pockets by staple assembly 120.

[0066] Anvil 130 may further include one or more driver(s) (not shown) within shaft 134 that have a distal end portion coupled to the pivot joints between shaft 134 and central component 140 and / or the pivot joints between lateral components 142, 144 and central component 140 for pivoting or rotating these components relative to each other. Alternatively, the driver(s) may be disposed within the circular stapler assembly 120, or within a separate anvil delivery instrument (not shown). The driver(s) may have a proximal end coupled to a suitable actuation mechanism (discussed in more detail below).

[0067] Referring now to FIG. 3, an anvil delivery instrument 200 includes an elongate shaft 202 sized to advance through a suitable percutaneous penetration in the patient, such as a trocar, cannular and the like. In certain embodiments, shaft 202 has an outer dimension of less than about 14 mm, although it will be recognized that the dimensions of shaft 202 may vary depending on the surgical procedure and the size of the percutaneous entry point into the patient.

[0068] Instrument 200 further includes first and second jaws 204, 206, that are movable between open and closed positions relative to each other. In certain embodiments, second jaw 206 is a movable jaw configured to move from an open position to a closed position relative to first jaw 204. In other embodiments, first jaw 204 is a movable jaw configured to move between open and closed positions relative to second jaw 206. In the exemplary embodiment, both jaws 204, 206 are movable relative to each other.

[0069] Referring to FIG. 7, jaws 204, 206 preferably pivot about a hinge that may include a pivot pin 210 extending through a slot (not shown) in each of the jaws 204, 206. Instrument 200 includes a driver (not shown) within shaft 202 that opens and closes jaws 204, 206 about pivot pin 210. Jaws 204, 206 may be opened and closed may any suitable mechanisms including, but not limited to, those described in any of the publications incorporated herein by reference. First and second jaws 204, 206 may also be capable of articulating together relative to shaft 202 about an axis substantially perpendicular to the longitudinal axis (e.g., the yaw or pitch axes). In these embodiments, instrument 200 may further include a wrist assembly (not shown) that allows jaws 204, 206 to articulate relative to shaft 202.

[0070] In an exemplary embodiment, jaws 204, 206 are configured to move into a substantially parallel position with each other in the closed position (as shown in FIG. 7). Jaws 204, 206 are preferably sized such that each jaw contacts and grips onto an outer surface of anvil shaft 134 in the closed position. This configuration provides a stronger grip on shaft 134 and inhibits the shaft from watermelon seeding from the jaws, as is the case with typical prior art instruments that do not close in a substantially parallel orientation.

[0071] In an exemplary embodiment, jaw 204 includes a jaw grasping portion 240 and a proximal support 242. Proximal support 242 extends downward towards a jaw grasping portion 244 of jaw 206 and is coupled thereto by pivot pin 210. Proximal support 242 is sized and shaped such that pivot pin 210 is located closer to jaw grasping portion 244 of jaw 206 than jaw grasping portion 242 of jaw 204. Thus, pin 210 and grasping portion 242 are disposed on one side of a central longitudinal axis 250 of shaft 202 and jaw grasping portion 240 is located on the other side of longitudinal axis 250. This provides an asymmetrical location for the hinge or pivot point between jaws 204, 206 such that the jaws can be position in a closed position around shaft 134 of anvil 130 with substantially parallel surfaces facing shaft 134.

[0072] Referring again to FIG. 3, delivery instrument 200 includes a driver for moving anvil head 132 between the collapsed and expanded configurations. In one embodiment, the driver comprises a rod 220 that extends through shaft 202. Rod 220 includes a distal end portion 222 configured to extend at least partially through jaws 204, 206. In one embodiment, rod 220 is sized and configured to extend through an internal lumen (not shown) in anvil shaft 134 and is configured for distal advancement through shaft 134 to engage anvil head 132 (see FIGS. 4 and 5). Rod 220 includes an engagement mechanism (not shown) on distal end portion 222 that cooperates with an engagement mechanism on anvil head 134 to move anvil head 132 between the collapsed and expanded configurations.

[0073] In one embodiment, rod 220 includes a rotatable element (not shown) configured to rotate relative to rod 220. In another embodiment, the entire rod 220 is configured to rotate relative to shaft 202. Rotation of rod 220 or the rotation element causes central component 140 of anvil head 132 to pivot about a hinge on anvil shaft 134 between the collapsed and expanded configurations. In addition, rotation of rod 220 causes lateral components 142, 144 to pivot about hinges between lateral components 142, 144 and central component 140. In an alternative embodiment, instrument 200 includes a second driver on rod 220 or on another element of instrument 200 that causes lateral components 142, 144 to pivot relative to central component 140 (i.e., movement of anvil head 132 into the collapsed configuration may be caused by a single or multiple drivers in instrument 200).

[0074] In another embodiment, distal end portion 222 of rod 220 is configured to actuate anvil head 232 through a push-pull mechanism. For example, longitudinal movement of rod 220 relative to instrument 200 causes central component 240 to pivot about anvil shaft 134 and / or lateral components 242, 244 to pivot about central component 240.

[0075] The proximal end portion of instrument 200 is operatively connected to an actuation mechanism (not shown), although as those skilled in the art reading this description will appreciate, components of the actuation mechanism may extend into, and / or pass through instrument 200. In various embodiments, instrument 200 will include a proximal handle (not shown) for actuating jaws 204, 206 and rod 220 and, in some embodiments, for controlling the orientation and movement of the distal end portion of instrument 200. In other embodiments, instrument 100 is adapted to be used with a robotic system. In these embodiments, instrument 100 will generally include an actuation mechanism that controls the orientation and movement of the end effector, the opening and closing of jaws 204, 206 and the actuation of rod 220. The actuation mechanism will typically be controlled by a robotic manipulator assembly that is controlled remotely by a user. For example, in one configuration, the actuation mechanism will be manipulated by the robotic manipulator assembly to either rotate rod 220 or move rod 220 in the longitudinal direction for expanding and collapsing anvil 230.

[0076] The actuation mechanism may include input couplers (not shown) instead of, or in addition to, the stationary and movable handles. In certain embodiments, surgical instrument 200 will further include a backend mechanism or proximal housing 540 (see FIG. 10B) coupled to the proximal end portion of elongate shaft 202 (discussed in more detail below). Backend mechanism 540 may be the same component as backend mechanism 510 shown in FIG. 10A, or it may be a different component.

[0077] Referring to FIG. 8, circular stapling instrument 100 and anvil delivery instrument 200 form a system that is particularly useful for joining two tubular structures in a patient, such as arteries, veins, and / or intestinal tissue 302. For example, in a lower colon procedure, the surgeon typically uses a conventional linear stapler with two rows of staples placed on either side of the affected intestinal lesion to be removed and stapled. The target area is cut at the same time as the adjacent ends are stapled. After removing the affected area, the surgeon typically inserts anvil 130 of instrument 100 into the proximal end of the lumen, proximal of the staple line. This is done by inserting anvil head 132 into an entrance that has been cut into the proximal lumen by the surgeon. In some embodiments, anvil 130 is placed transanally by placing anvil head 132 at the distal end of instrument 200 and inserting instrument 200 through the rectum.

[0147] While several embodiments have been shown in the drawings, it is not intended that the description be limited thereto, as it is intended that the description be as broad in scope as the art will allow and that the specification be read likewise. Therefore, the above description should not be construed as limiting, but merely as exemplifications of presently disclosed embodiments. Thus the scope of the embodiments should be determined by the appended claims and their legal equivalents, rather than by the examples given.

[0148] Further, this description's terminology is not intended to limit the devices described herein. The term "force" is to be construed as encompassing both force and torque, unless otherwise indicated herein or clearly contradicted by context. The terms "tools" and "instruments" are used interchangeably herein to refer to the surgical instruments. As used in this specification and the appended claims, the singular forms "a," "an," and "the," and any singular use of any word, include plural referents unless expressly and unequivocally limited to one referent. The terms "comprising," "having," "including," and "containing" are to be construed as open-ended terms (i.e., meaning "including, but not limited to,") unless otherwise noted. The terms "connected" and "coupled" are to be construed as partly or wholly contained within, attached to, or joined together, even if there is something intervening.

[0149] Spatially relative terms—such as "proximal" and "distal—may be used to describe one element's or feature's relationship to another element or feature as illustrated in the figures. These spatially relative terms are intended to encompass different positions (i.e., locations) and orientations (i.e., rotational placements) of a device in use or operation in addition to the position and orientation shown in the figures. For example, the terms "proximal" and "distal" are relative terms, where the term "distal" refers to the portion of the object furthest from an operator of the instrument and closest to the surgical site, such as the opening of the tool cover or the end effector of the instrument. The term "proximal" indicates the relative proximity to the operator of the surgical instrument and refers to the portion of the object closest to the operator and furthest from the surgical site. In this application, an end effector refers to a tool installed at the distal end of an instrument, including but not limited to forceps or graspers, needle drivers, scalpels, scissors, spatulas, blades, and other tools, which may or may not use energy to cauterize tissue (i.e., a monopolar or bipolar tool).

[0150] Persons skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Various alternatives and modifications can be devised by those skilled in the art without departing from the disclosure. Accordingly, the present description is intended to embrace all such alternatives, modifications and variances. As well, one skilled in the art will appreciate further features and advantages of the present disclosure based on the above-described embodiments. Accordingly, the present description is not to be limited by what has been particularly shown and described, except as indicated by the appended claims.

[0151] For example, a first embodiment is a delivery instrument for a circular stapler having an anvil, the instrument comprising: an elongate shaft with first and second jaws movable between open and closed positions; and a driver extending through the shaft, the driver including an engagement mechanism for engaging the anvil and moving the anvil between a collapsed configuration with a first lateral dimension and an expanded configuration with a second lateral dimension, wherein the first lateral dimension is smaller than the second lateral dimension.

[0152] A second embodiment is the first embodiment, wherein the driver comprises a rod extending at least partially through the first and second jaws.

[0153] A third embodiment is any combination of the above embodiments, wherein the engagement mechanism comprises a rotatable element on a distal end of the rod.

[0154] A 4th embodiment is any combination of the above embodiments, wherein the driver rod is rotatable relative to the elongate shaft of the instrument.

[0155] A 5th embodiment is any combination of the above embodiments, wherein the driver rod is movable in a longitudinal direction relative to the elongate shaft of the instrument.

[0156] A 6th embodiment is any combination of the above embodiments, wherein rotation of the rod causes the anvil to move from the collapsed configuration to the expanded configuration.

[0157] A 7th embodiment is any combination of the above embodiments, wherein longitudinal movement of the rod causes the anvil to move from the collapsed configuration to the expanded configuration.

[0158] An 8th embodiment is any combination of the above embodiments, wherein the anvil comprises a head and a proximal shaft, wherein the first and second jaws are sized to contact and engage an outer surface of the proximal shaft in the closed position.

[0159] A 9th embodiment is any combination of the above embodiments, wherein the first and second jaws are substantially parallel in the closed position.

[0160] A 10th embodiment is any combination of the above embodiments, wherein the first and second jaws comprise first and second jaw grasping portions pivotably coupled to each other about a hinge.

[0161] An 11th embodiment is any combination of the above embodiments, wherein the shaft comprises a central longitudinal axis, wherein the first jaw grasping portion is disposed on a first side of the central longitudinal axis and the second jaw grasping portion and the hinge are disposed on a second side of the central longitudinal axis opposite the first side.

[0162] A 12th embodiment is any combination of the above embodiments, wherein the driver is configured for coupling to a robotic control system.

[0163] A 13th embodiment is a circular stapler system comprising: a staple assembly comprising a plurality of staples and a cutting element; an anvil movably coupled to the stapling assembly and configured for deploying between a collapsed configuration with a first lateral dimension and an expanded configuration with a second lateral dimension, wherein the first lateral dimension is smaller than the second lateral dimension; and a delivery instrument comprising an engagement mechanism for engaging the anvil and moving the anvil from the collapsed configuration to the expanded configuration.

[0164] A 14th embodiment is the 13th embodiment and any combination of the above embodiments.

[0165] A 15th embodiment is any combination of the above embodiments, wherein the anvil is pivotable between the collapsed and expanded configurations.

[0166] A 16th embodiment is any combination of the above embodiments, wherein the anvil comprises a head and a shaft, wherein the head is pivotable relative to the shaft from the collapsed configuration, wherein the head is oriented substantially parallel with the shaft, to the expanded configuration, wherein the head is oriented substantially perpendicular to the shaft.

[0167] A 17th embodiment is any combination of the above embodiments, wherein the engagement mechanism comprises a driver extending at least partially between the first and second jaws.

[0168] An 18th embodiment is any combination of the above embodiments, wherein the engagement mechanism comprises a rotatable element on a distal end of the driver.

[0169] A 19th embodiment is any combination of the above embodiments, wherein the driver is rotatable relative to the elongate shaft of the instrument.

[0170] A 20th embodiment is any combination of the above embodiments, wherein the driver is movable in a longitudinal direction relative to the elongate shaft of the instrument.

[0171] A 21st embodiment is any combination of the above embodiments, wherein rotation of the driver causes the anvil to pivot from the collapsed configuration to the expanded configuration.

[0172] A 22nd embodiment is any combination of the above embodiments; wherein longitudinal movement of the driver causes the anvil to pivot from the collapsed configuration to the expanded configuration.

[0173] A 23rd embodiment is any combination of the above embodiments, wherein the driver is configured for coupling to a robotic control system.

[0174] A 24th embodiment is any combination of the above embodiments, wherein the anvil has a lateral dimension of less than about 14 mm in the collapsed configuration.

[0175] A 25th embodiment is any combination of the above embodiments, wherein the anvil has a lateral dimension of at least about 20 mm in the expanded configuration.

[0176] A 26th embodiment is a robotic control system comprising: a circular stapler comprising a staple assembly and an anvil movably coupled to the staple assembly; an instrument configured for moving the anvil from a collapsed configuration with a first diameter to an expanded configuration with a second diameter, wherein the first diameter is smaller than the second diameter; and a robotic controller configured to control the instrument.

[0177] A 27th embodiment is the 26th embodiment and any combination of the above embodiments.

[0178] A 28th embodiment is any combination of the above embodiments, further comprising an input device coupled to the controller and movable by the user such that movement of the input device generates an input signal, wherein the controller is configured to move the anvil from the collapsed configuration to the expanded configuration based on the input signal.

[0179] A 29th embodiment is any combination of the above embodiments, further comprising a sensor coupled to the controller for detecting a force or torque applied by the robotic controller to the instrument.

[0180] A 30th embodiment is any combination of the above embodiments, further comprising a sensor coupled to the controller for detecting a force or torque applied by the instrument to the anvil.

[0181] A 31st embodiment is any combination of the above embodiments, wherein the instrument comprises first and second jaws movable between open and closed positions and a driver extending at least partially through the first and second jaws.

[0182] A 32nd embodiment is any combination of the above embodiments, wherein the controller is configured to rotate the driver to cause the anvil to move from the collapsed configuration to the expanded configuration.

[0183] A 33rd embodiment is any combination of the above embodiments, wherein the controller is configured to move the driver longitudinally relative to the instrument shaft to cause the anvil to move from the collapsed configuration to the expanded configuration.

[0184] A 34th embodiment is a method of joining two tubular tissue structures, the method comprising: introducing an anvil in a collapsed configuration through a cannula adjacent to a first tissue structure within a patient; moving the anvil from the collapsed configuration into an expanded configuration; positioning a staple assembly adjacent to a second tissue structure within the patient; and advancing a plurality of staples into the first and second tissue structures to attach the first tissue structure to the second tissue structure.

[0185] A 35th embodiment is the 34th embodiment and any combination of the above embodiments.

[0186] A 36th embodiment is any combination of the above embodiments, further comprising moving the anvil from the expanded configuration to the collapsed configuration to remove the anvil from the patient.

[0187] A 37th embodiment is any combination of the above embodiments, further comprising grasping a shaft of the anvil to move the anvil to the first tissue structure.

[0188] A 38th embodiment is any combination of the above embodiments, further comprising rotating a driver within a delivery instrument to move the anvil into the expanded configuration.

[0189] A 39th embodiment is any combination of the above embodiments, further comprising moving a driver within a delivery instrument in a longitudinal direction to move the anvil into the expanded configuration.

[0190] A 40th embodiment is any combination of the above embodiments, wherein the first and second tissue structures comprise first and sections of an intestine

Claims

1. A delivery instrument for a circular stapler having an anvil, the instrument comprising:an elongate shaft with first and second jaws movable between open and closed positions; anda driver extending through the shaft, the driver including an engagement mechanism for engaging the anvil and moving the anvil between a collapsed configuration with a first lateral dimension and an expanded configuration with a second lateral dimension, wherein the first lateral dimension is smaller than the second lateral dimension.

2. The delivery instrument of claim 1, wherein the driver comprises a rod extending at least partially through the first and second jaws.

3. The delivery instrument of claim 2, wherein the engagement mechanism comprises a rotatable element on a distal end of the rod.

4. The delivery instrument of any one of claims 2 to 3, wherein the driver rod is rotatable relative to the elongate shaft of the instrument.

5. The delivery instrument of any one of claims 2 to 4, wherein the driver rod is movable in a longitudinal direction relative to the elongate shaft of the instrument.

6. The delivery instrument of claim 4, wherein rotation of the rod causes the anvil to move from the collapsed configuration to the expanded configuration.

7. The delivery instrument of claim 5, wherein longitudinal movement of the rod causes the anvil to move from the collapsed configuration to the expanded configuration.

8. The delivery instrument of any one of claims 1 to 7, wherein the anvil comprises a head and a proximal shaft, wherein the first and second jaws are sized to contact and engage an outer surface of the proximal shaft in the closed position.

9. The delivery instrument of claim 8, wherein the first and second jaws are substantially parallel in the closed position.

10. The delivery instrument of any of claims 1 to 9, wherein the first and second jaws comprise first and second jaw grasping portions pivotably coupled to each other about a hinge.

11. The delivery instrument of claim 10, wherein the shaft comprises a central longitudinal axis, wherein the first jaw grasping portion is disposed on a first side of the central longitudinal axis and the second jaw grasping portion and the hinge are disposed on a second side of the central longitudinal axis opposite the first side.

12. The delivery instrument of any of claims 1 to 11, wherein the driver is configured for coupling to a robotic control system.

13. A circular stapler system comprising:a staple assembly comprising a plurality of staples and a cutting element;an anvil movably coupled to the stapling assembly and configured for deploying between a collapsed configuration with a first lateral dimension and an expanded configuration with a second lateral dimension, wherein the first lateral dimension is smaller than the second lateral dimension; anda delivery instrument comprising an engagement mechanism for engaging the anvil and moving the anvil from the collapsed configuration to the expanded configuration.

14. The system of claim 13, wherein the anvil is pivotable between the collapsed and expanded configurations.

15. The system of any one of claims 13 to 14, wherein the anvil comprises a head and a shaft, wherein the head is pivotable relative to the shaft from the collapsed configuration, wherein the head is oriented substantially parallel with the shaft, to the expanded configuration, wherein the head is oriented substantially perpendicular to the shaft.

16. The system of claim 15, wherein the engagement mechanism comprises a driver extending at least partially between the first and second jaws.

17. The system of claim 16, wherein the engagement mechanism comprises a rotatable element on a distal end of the driver.

18. The system of any one of claims 16 to 17, wherein the driver is rotatable relative to the elongate shaft of the instrument.

19. The system of any one of claims 16 to 18, wherein the driver is movable in a longitudinal direction relative to the elongate shaft of the instrument.

20. The system of claim 18, wherein rotation of the driver causes the anvil to pivot from the collapsed configuration to the expanded configuration.

21. The system of claim 19, wherein longitudinal movement of the driver causes the anvil to pivot from the collapsed configuration to the expanded configuration.

22. The system of any one of claims 13 to 21, wherein the driver is configured for coupling to a robotic control system.

23. The system of any one of claims 13 to 22, wherein the anvil has a lateral dimension of less than about 14 mm in the collapsed configuration.

24. The system of any one of claims 13 to 23, wherein the anvil has a lateral dimension of at least about 20 mm in the expanded configuration.

25. The system of any one of claim 13 to 24, wherein the anvil head comprises first and second components movable relative to each other and configured for deploying between a collapsed configuration with a first lateral dimension and an expanded configuration with a second lateral dimension, wherein the first lateral dimension is smaller than the second lateral dimension.

25. The system of claim 24, wherein the first and second components of the anvil head are pivotable relative to the shaft between the collapsed configuration, wherein the anvil head is oriented substantially parallel with the shaft, and the expanded configuration, wherein the anvil head is oriented substantially perpendicular to the shaft.

26. The system of claim 25, wherein the anvil head comprises a central component pivotally coupled to the shaft, wherein the first and second components are pivotally coupled to the central component.

27. The system of any of claims 13 to 24, wherein the head comprises a plurality of petals each comprising a tissue contacting surface defining staple forming pockets, wherein the petals are configured for deploying between a collapsed configuration with a first lateral dimension and an expanded configuration with a second lateral dimension, wherein the first lateral dimension is smaller than the second lateral dimension.

28. The system of any of claims 13 to 24, wherein the anvil comprises an expandable element coupled to the annular tissue contact surface and configured for deploying between a collapsed configuration with a first lateral dimension and an expanded configuration with a second lateral dimension, wherein the first lateral dimension is smaller than the second lateral dimension.

29. A robotic control system comprising:a circular stapler comprising a staple assembly and an anvil movably coupled to the staple assembly;an instrument configured for moving the anvil from a collapsed configuration with a first diameter to an expanded configuration with a second diameter, wherein the first diameter is smaller than the second diameter; anda robotic controller configured to control the instrument.

30. The control system of claim 29, further comprising an input device coupled to the controller and movable by the user such that movement of the input device generates an input signal, wherein the controller is configured to move the anvil from the collapsed configuration to the expanded configuration based on the input signal.

31. The control system of any of claims 29 to 30, further comprising a sensor coupled to the controller for detecting a force or torque applied by the robotic controller to the instrument.

32. The control system of any of claims 29 to 31, further comprising a sensor coupled to the controller for detecting a force or torque applied by the instrument to the anvil.

33. The control system of any of claims 29 to 32, wherein the instrument comprises first and second jaws movable between open and closed positions and a driver extending at least partially through the first and second jaws.

34. The control system of claim 33, wherein the controller is configured to rotate the driver to cause the anvil to move from the collapsed configuration to the expanded configuration.

35. The control system of claim 33, wherein the controller is configured to move the driver longitudinally relative to the instrument shaft to cause the anvil to move from the collapsed configuration to the expanded configuration.

36. A method of joining two tubular tissue structures, the method comprising:introducing an anvil in a collapsed configuration through a cannula adjacent to a first tissue structure within a patient;moving the anvil from the collapsed configuration into an expanded configuration;positioning a staple assembly adjacent to a second tissue structure within the patient; andadvancing a plurality of staples into the first and second tissue structures to attach the first tissue structure to the second tissue structure.

37. The method of claim 36, further comprising moving the anvil from the expanded configuration to the collapsed configuration to remove the anvil from the patient.

38. The method of any of claims 36 to 37 further comprising grasping a shaft of the anvil to move the anvil to the first tissue structure.

39. The method of any of claims 36 to 38, further comprising rotating a driver within a delivery instrument to move the anvil into the expanded configuration.

40. The method of any of claims 36 to 39, further comprising moving a driver within a delivery instrument in a longitudinal direction to move the anvil into the expanded configuration.

41. The method of any of claims 36 to 40, wherein the first and second tissue structures comprise first and sections of an intestine

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